The following data is part of a premarket notification filed by Pilling Co. with the FDA for Mehigan-pilling Phlebetome Tm.
Device ID | K911100 |
510k Number | K911100 |
Device Name: | MEHIGAN-PILLING PHLEBETOME TM |
Classification | Valvulotome |
Applicant | PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Contact | Richard G Jones |
Correspondent | Richard G Jones PILLING CO. 420 DELAWARE DR. Fort Washington, PA 19034 |
Product Code | MGZ |
CFR Regulation Number | 870.4885 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-03-12 |
Decision Date | 1991-06-21 |